UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017657
Receipt No. R000020466
Scientific Title Study of prevention of hair loss induced by chemotherpy for Japanese breast cancer patients with scalp cooling
Date of disclosure of the study information 2015/06/01
Last modified on 2015/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of prevention of hair loss induced by chemotherpy for Japanese breast cancer patients with scalp cooling
Acronym Hair loss prevention with scalp cooling
Scientific Title Study of prevention of hair loss induced by chemotherpy for Japanese breast cancer patients with scalp cooling
Scientific Title:Acronym Hair loss prevention with scalp cooling
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and safety of scalp cooling during chemotherapy administration to prevent hair loss
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of grade 3 or 4 of hair loss, according to WHO classification, or use of a wig or a hat
Key secondary outcomes Degrees of hair loss assessed by patients
Patients' satisfaction
Patients' thoughts
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Scalp Cooling
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with breast cancer
Applicants of chemotherapy
Key exclusion criteria Patients with Raynaud's disease or phenomenon
Patients with high degree alopecia who need a wig
Patients with cold agglutinin disease
Patients with cryoglobulinemia
Patients with cryofibrinogenemia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Ohsumi
Organization NHO Shikoku Cancer Center
Division name Breast Oncology
Zip code
Address 160 Kou, Minami-umemoto-machi, Matsuyama, Ehime
TEL 089-999-1111
Email sosumi@shikoku-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shozo Ohsumi
Organization NHO Shikoku Cancer Center
Division name Breast Oncology
Zip code
Address 160 Kou, Minami-umemoto-machi, Matsuyama, Ehime
TEL 089-999-1111
Homepage URL
Email sosumi@shikoku-cc.go.jp

Sponsor
Institute Department of Breast Oncology, NHO Shikoku Cancer Center
Institute
Department

Funding Source
Organization NHO Shikoku Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2015 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 24 Day
Last modified on
2015 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.